reflux esophagitis
Conditions
Interventions
experiment group:Lansoprazole and sodium bicarbonate capsules (Lansoprazole 30mg and sodium bicarbonate 1100mg), taken orally on an empty stomach before meal in the morning, once a day, 1 capsule each
control group1:Lansoprazole enteric capsules (Lansoprazole 30mg), taken orally on an empty stomach before meal in the morning, once a day, 1 capsule each time
control group2:Omeprazole and sodium bicarbonate capsules (Lansoprazole 30mg and sodium bicarbonate 1100mg), taken orally on an empty stomach before meal in the morning, once a day, 1 capsule each tim
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.18-75 years old, male or female; 2. Within 7 days before randomization, subjects were endoscopically confirmed erosive oesophagitis (Los Angeles classification grade A-D) ; 3. Heartburn or reflux symptoms; 4. Patients who can independently complete the subject diary card record.
Exclusion criteria
Exclusion criteria: 1. Endoscopic examination found concomitant diseases that may affect the esophagus except reflux esophagitis; 2. Patients with rheumatic immune diseases that may affect esophageal motility (such as scleroderma, undifferentiated connective tissue disease, etc.), or with a history of esophageal radiotherapy or esophageal cryotherapy; 3. Subjects with active peptic ulcer or suspected or confirmed malignant tumor detected by upper gastrointestinal endoscopy; 4. Subjects who are known to have Drachalasia syndrome, achalasia of cardia, or inflammatory bowel disease; 5. Previous operations affecting the structure or function of the esophagus, stomach and duodenum, or operations affecting the secretion of gastric acid; 6. Therapeutic doses of GERD drugs, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, mucosal protective drugs, gastrointestinal mototropic drugs, and proprietary Chinese medicines for GERD were used within 7 days prior to randomization; 7. Subjects used NSAIDS (including coX-2 inhibitors), systemic glucocorticoids, antiplatelet drugs (such as aspirin, clopidogrel, etc.), anticoagulants (warfarin, etc.) for a long time before screening and could not be discontinued during the test; 8. Used bisphosphonates within 1 month before screening; 9. Subjects who were taking Azanavir sulfate or Ripiavirin hydrochloride at the time of screening; 10. The subject has serious diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal system, urinary system, endocrine system or blood system, which the investigator believes may confuse the study results or affect the safety of the subject; 11, screening period laboratory examination showed ALT or AST > 1.5 times the upper limit of normal value, or Cr > the upper limit of normal value of renal function (the study allowed for 1 review, if still do not meet the requirements of inclusion excluded); 12. At the time of screening, subjects with clinically significant ECG abnormalities, including severe arrhythmia, multiventricular precontraction, atrioventricular block of degree II or above, and prolonged QTc interval (QTc=450ms in men and QTc=470ms in women); 13. Female subjects who plan to become pregnant during pregnancy, lactation or during the trial. Women of reproductive age who, in the investigator's judgment, were unable to use a medically approved and reliable method of contraception within 4 weeks of signing the informed consent to the final dosing of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First day of complete heartburn relief (median time from the start of medication to complete relief of heartburn);Changes of serum gastrin from baseline at 4 and 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| the percentage of subjects with healing by week 4;the percentage of subjects with healing by week 8;The proportion of time (hours) without heartburn symptoms on day 1 and week 1 of the study;The change of GERD-HRQL score from baseline in patients with reflux esophagitis at week 1, 4 and 8;The frequency and severity of each single clinical symptom (heartburn and reflux) of reflux esophagitis at week 1, 4 and 8 of the study, as well as the partial relief rate after treatment (the score of symptom severity after treatment was lower than that before treatment by =1 point) and the complete relief rate (the score of frequency and severity were 0 points, that is, the symptoms disappeared).;Overall complete relief rate of clinical symptoms of reflux esophagitis at week 1, 4, and 8 (heartburn and reflux response); | — |
Countries
China
Contacts
Public ContactJingyuan Fang
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed